Hybridoma technology as developed by Kohler and Milstein is well established as a method of producing antibodies of pre-determined specificity (Kohler G. and Milstein C., 1975, Nature (London), 256, 494-497. See, for example, U.S. Pat. Nos. 4,172,124, 4,196,265 and 4,522,918 which teach monoclonal antibody production by hybridoma techniques. Solid phase radioimmunoassay (Colcher et al, 1981, Cancer Research 41, 1451-1459) and enzyme linked immunosorbent assay (Methods in Enzymology (73); Immunochemical Techniques, Pt B, pp. 471-550 London, Academic Press, (1981) Phillips and Lewis, Aust. N. Z.. Journal of Surgery 48(5), 545-549, October 1978).
Background art regarding monoclonal antibodies and reactivity in colonic effluent material is outlined in Tobi et al, Gastroenterology, May 1987, Vol. 92 No. 5, p 1672 and Tobi et al, Gastroenterology, December 1988, Vol. 95, pp. 1693-1694. Current non-invasive screening for colorectal cancer in an average risk population involves the detection of occult blood in the stools, a technique that has been found lacking in Simon, 1985, Gastroenterology, 88, 820-837.
Detection of tumor antigens such as carcinoembryonic antigen (CEA) in blood and/or colonic lavage has not been diagnostic for colorectal cancer at all locations when using polyclonal antibodies and physico-chemical methods as discussed in Winawer et al, Gastroenterology, 1977, Vol. 73, pp. 719-722, and Vellacott et al, Clinical Oncology, 1982, Vol. 8, pp. 61-67. Detection of CEA in feces may aid in diagnosis as discussed in Freed et al, British Medical Journal, 1972, Vol. 1, pp 85-87; Elias et al, Diseases of the Colon and Rectum, 1974, Vol. 17, pp 38-41; Stubbs et al, 1986, Vol. 27, pp 901-905.
Diagnosis of early neoplastic change in the human colon might be enhanced by detection of an early tumor marker found on benign adenomatous colon polyps, which would be a distinct departure from the conventional approach. However, immunization of mice with colonic adenoma tissue yielded a monoclonal antibody reactive with a blood group substance (BGA) found in colorectal cancers (Brown et al, Bioscience Reports, 1983, Vol. 3, pp 163-170).
A need continues to exist for a method of producing antibodies reactive with human colonic tissue and for a method of detecting and diagnosing colorectal cancer.